FDA.reportPublic FDA data

Tramadol Hydrochloride

Product NDC
55700-997
11-digit product format
557000997
Labeler code
55700
Product ID
55700-997_47fed614-6d8f-440b-af12-51ffa022167d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA208708
Marketing category
ANDA
Marketing start
2023-02-07
Marketing end
2026-11-30
Substance
TRAMADOL HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tramadol Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui835603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-997-01Tramadol Hydrochloride120 in 1 BOTTLETABLET, COATED1202
55700-997-15Tramadol Hydrochloride15 in 1 BOTTLETABLET, COATED152
55700-997-18Tramadol Hydrochloride180 in 1 BOTTLETABLET, COATED1802
55700-997-24Tramadol Hydrochloride240 in 1 BOTTLETABLET, COATED2402
55700-997-30Tramadol Hydrochloride30 in 1 BOTTLETABLET, COATED302
55700-997-60Tramadol Hydrochloride60 in 1 BOTTLETABLET, COATED602
55700-997-90Tramadol Hydrochloride90 in 1 BOTTLETABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-997-01EA - Each55700-997d3bf2389-3a7c-4120-b2a9-5f088509287b12023-03-13
55700-997-15EA - Each55700-997e9518b76-9ae7-4235-9069-510b9c985a9a12023-03-13
55700-997-18EA - Each55700-99795e22f66-043f-4a63-b1ab-0094d7e3089012023-03-13
55700-997-24EA - Each55700-997e4eedacb-bd73-4b55-9c7a-36788f42b49d12023-03-13
55700-997-30EA - Each55700-99742b7cd9e-0172-4ab2-abfc-25ba15f7437912023-03-13
55700-997-60EA - Each55700-997e56bf8f9-e975-4a5f-825f-da83dce9754412023-03-13
55700-997-90EA - Each55700-9977e2f1fbf-05d2-4a7c-85cd-d314197cce4612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-997TRAMADOL HYDROCHLORIDE TABLET, COATED [QUALITY CARE PRODUCTS, LLC]2Current NDC, 7 package rows20241222_f79fda81-f09a-4a08-babc-6bd3bb3ee661.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835603traMADol HCl 50 MG Oral TabletPSNf79fda81-f09a-4a08-babc-6bd3bb3ee6612
835603tramadol hydrochloride 50 MG Oral TabletSCDf79fda81-f09a-4a08-babc-6bd3bb3ee6612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-997-0155700099701120 TABLET, COATED in 1 BOTTLE (55700-997-01) 2023-02-072026-11-30NoNoHistorical
55700-997-155570009971515 TABLET, COATED in 1 BOTTLE (55700-997-15) 2023-02-072026-06-30NoNoHistorical
55700-997-1855700099718180 TABLET, COATED in 1 BOTTLE (55700-997-18) 2023-02-072026-11-30NoNoHistorical
55700-997-2455700099724240 in 1 BOTTLEHistorical
55700-997-305570009973030 TABLET, COATED in 1 BOTTLE (55700-997-30) 2023-02-072026-11-30NoNoHistorical
55700-997-605570009976060 TABLET, COATED in 1 BOTTLE (55700-997-60) 2023-02-072026-11-30NoNoHistorical
55700-997-905570009979090 TABLET, COATED in 1 BOTTLE (55700-997-90) 2023-02-072026-11-30NoNoHistorical